Shots:

• The approval was based on the clinical program including two P-III TULIP & P-II MUSE trials evaluated the efficacy and safety of Saphnelo vs PBO in 362 & 305 patients with SLE who are receiving standard therapy
• The results showed a reduction in overall disease activity across organ systems- including skin and joints- and achieved a sustained reduction in OCS across both groups
• Saphnelo marks the first regulatory approval for a type I IFN receptor antagonist in Japan & has approved in the US for the same indication. The therapy is under regulatory review for SLE in the EU & company plans for an additional P-III trial for LN- CLE & myositis

  | Ref: AstraZeneca | Image: Mint